Sr Mgr Clinical Drug Supply & Logistics

About the role

The Senior Manager, Clinical Drug Supply & Logistics is responsible for overseeing clinical programs, forecasting IP supply requirements, and managing the IP distribution process. This role applies to both internally sourced studies and CRO/Partnered studies.

Responsibilities

• Serves as lead drug supply manager of a program and/or individual studies for supply planning, including demand forecasting according to IOPS requirements.
• Manages supply planning and timelines to ensure alignment with study plans and timelines and overall clinical development plan.
• Determines resourcing needs and provides input to the development of IP-related study documents including protocols, study and pharmacy manuals.
• Works within established timelines of investigational product manufacturing, labeling, release, distribution and return/destruction, or helps establish these timelines.
• Manages and oversees investigational product (IP) inventory strategy; advises supply management team of potential shortages and defines resupply activities based on usage trends and projections.
• Oversees IP shipment orders according to supply plans or as requested by Clinical Trial Management team, ensuring timely and compliant shipment and delivery to investigator sites.
• Coordinates with other functional areas, including Regulatory, Medical Director, Forecasting & Planning, and IOPS to define ancillary and/or comparator supply strategy.
• Develops plans for supplying clinical study sites with ancillary and/or comparator supplies, either through in-house initiated supply or working with supply vendors.
• Provides input to drug kit randomization specifications and reviews and approves master kit lists. Designs, reviews, and approves IP-related study tools (for clinical study teams and investigative site use), as needed.
• Supports inspection team in preparation for and during regulatory agency inspection. May represent Clinical Drug Supply & Logistics during regulatory agency inspections.
• Represents Clinical Drug Supply & Logistics on cross-functional study team(s) and/or sub-team(s). Prepares or provides input into IP-related content for training materials and coordinates training on study procedures.
• Collaborates with the CTM for study, providing input into IP-related study specific working practices. Establishes study team contacts, roles, responsibilities, and objectives for IP-related services; develops, manages, and maintains relationships with external partners.
• Communicates effectively with CROs, shipping and IVRS vendors, study sites, and study team members to ensure ongoing successful execution. Acts as point of escalation for IP-related issues.
• Provides input into budgets, SoWs, contracts, and timelines for IP-related services. Creates RFPs, reviews quotes, and awards third-party vendors for distribution services.
• Manages IP service vendors (performance, quality, timelines, deliverables, costs). Participates in preparation of RFP, assumptions and SOW for CROs and IP services vendors (labeling, packaging, distribution; IVRS/IWRS). Provides input, reviews, and approves vendor study specifications for IP-related activities. Serves as point of escalation for vendor-related IP issues as they arise.
• May require 25% travel.
• Supervises staff. Mentors or coaches junior Clinical Drug Supply & Logistics staff.
• Develops and implements process initiatives in accordance with business needs.
• Tracks metrics related to drug supply processes and staff.
• Provides assistance in training and development as needed.
• Applies knowledge of company policies and standard practices to resolve problems.

Requirements

• A minimum of Bachelors' degree and 8 years of relevant experience in the biotechnology/pharmaceutical industry, with 5 years minimum in clinical supply management.
• Masters/MBA/PharmD with 5+ years of relevant industry experience.